Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

The primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesia Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Leuven, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or Female
The subject is an out-patient
Age 30 years or above
Dyskinesias present during more than 25% of the waking day
Dyskinesias at least moderately disabling
Written informed consent

Exclusion criteria

Pregnancy and/or lactation
Participation in another study within the last 30 days
Dementia or other psychiatric illness that prevents provision of informed consent
History of allergic disorders such as asthma
Known hypersensitivity to the study treatment(s)
Known hypersensitivity to ACTH

Treatment and study plan

Sarizotan HCl

Drug

Sponsors and collaborators

Lead sponsor

EMD Serono

Industry

Registry information

Official study title

A Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

Important dates

Study start: 2002
Study completion: 2003
First posted: Apr 13, 2006
Registry last updated: Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed